Hyland's Consumer Health Inc.
Form 483 issued November 29, 2022 · Los Angeles, California
- Investigator
- Santiago Gallardo Johnson
- Observations
- 5
- Pages
- 5
- FEI number
- 2010939
In short: On November 29, 2022, FDA issued a Form 483 with 5 observations to Hyland's Consumer Health Inc. in Los Angeles, California (FEI 2010939). The investigator was Santiago Gallardo Johnson. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into the failure of a batch or any of its components to…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
EMPLOYEE{S) SIGNATURE The master production and control records are deficient in that they do not include…
This inspection in context
Santiago Gallardo Johnson
18 documents · 2017–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmHyland's Consumer Health Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hyland's Consumer Health Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Hyland's Consumer Health Inc.?
Santiago Gallardo Johnson is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Hyland's Consumer Health Inc. inspected by FDA?
This Form 483 is dated November 29, 2022.
How do I get the full Form 483 for Hyland's Consumer Health Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.